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• W2188900031 abstract "Electronic data-capturing (EDC) clinical database development experience for a large global postmarketing study was presented to illustrate how information technology (IT), standards, and systems development methodology were utilized to assist in the building of a clinical trial database, overcome challenges, and monitor benefits gained via partnering with both internal and external functional groups. Designing an electronic case report form (eCRF) is an interdisciplinary systems engineering task and requires not only technical skills in utilizing information technology (IT) tools and systems approach but also expertise and scientific reasoning in the subject-therapeutic areas. EDC technology may be utilized to facilitate clinical trials and industry-wide study initiatives by offering real-time data availability, automatic query management functionality, and improved data quality. The use of EDC and eCRF to collect data in clinical trials has grown to gradually replace paper-based collection (PDC) approach and affected the activities of clinical research operations for industry sponsors, clinical research organizations (CROs), and clinical sites [1]–[3]. An eCRF design must ensure superior data quality by following the clinical study protocols, corporate therapeutic or standard consortium guidelines, and good clinical practice rules with supportable technology. EDC technology must comply with applicable regulatory requirements and offer flexible, configurable, scalable, and auditable system features [4]. The design, development, and support of an eCRF database or clinical data management system (CDMS) for a clinical study must follow the systems development methodology to ensure compliance. Additionally, postmarketing safety data collection and clinical risk assessment based on observational data are critical for evaluating and characterizing a product’s risk profile and for making informed decisions on risk minimization [5]. Moreover, both payer groups and regulators require more postmarketing data from sponsor companies. Therefore, designing an eCRF to address postmarketing study safety and pharmacovigilance seems to be specifically challenging. A drug-eluting stent (DES) was approved by the U.S. Food and Drug Administration (FDA) on 2 July 2008 and was launched in Europe and other international markets in October 2006. Both the XIENCE USA and India studies were designed to evaluate this everolimus-eluting coronary stent system (EECSS) performance in the real world when used by a broad group of physicians at a variety of health-care facilities. The primary endpoint of these two studies is a measure of stent thrombosis every year out of five years, as defined by the Dublin/Academic Research Consortium (ARC). The ARC definition of late-stent thrombosis was developed to eliminate variability in the definitions across various DES trials. Adjunctive antiplatelet therapy is a critical factor in optimizing long-term DES safety. Despite established guidelines that recommend 6–12 months dual antiplatelet therapy, patients with DES implants frequently stop taking their medication early. Consequently, the postmarketing study followup will document patient adherence and persistence with adjunctive antiplatelet drug therapy at several time points throughout the study. Such long-term postmarketing studies may help elucidate mechanisms responsible for death, myocardial infarction, and latestent thrombosis risks not observed during controlled premarket trials (see Table 1 about the trial characteristics). The purpose of this article is to address three questions: What were the EDC technologies employed in a typical industrysponsored clinical study? How is the developed system meeting the clinical research need? What would we want more from this EDC technology? This article is prepared from industry perspectives to present and analyze the advantages, benefits, and challenges in applying EDC technologies to address industry’s clinical trial operational needs based on a systematic overview." @default.
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• W2188900031 title "Electronic Data-Capturing Technology for Clinical" @default.
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